- Device
- ALTRUA™ 2, ESSENTIO™, PROPONENT™, ACCOLADE™
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S275
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2022-11-08
- Decision code
- APPR
- Date received
- 2022-08-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software maintenance release to update the Model 3869 Brady programmer software application and Accolade pulse generator firmware.